{"id":418,"date":"2010-12-15T15:39:52","date_gmt":"2010-12-15T14:39:52","guid":{"rendered":"https:\/\/blogs.bmj.com\/heart-journalscan\/?p=418"},"modified":"2015-11-12T14:16:56","modified_gmt":"2015-11-12T13:16:56","slug":"evidence-mounts-to-re-ly-on-dabigatran","status":"publish","type":"post","link":"https:\/\/blogs.bmj.com\/heart\/2010\/12\/15\/evidence-mounts-to-re-ly-on-dabigatran\/","title":{"rendered":"Evidence mounts to RE-LY on dabigatran"},"content":{"rendered":"<p>Dabigatran etecxilate is a novel anti-coagulant that acts a direct thrombin inhibitor and provides stable anticoagulation at a fixed dose without any need for a laboratory control. In the RE-LY trial (Randomised Evaluation of Long-term Anticoagulation Therapy), dabigatran was shown to reduced strokes and peripheral embolic events in patients with atrial fibrillation when compared to warfarin; this superiority was seen at higher doses, although dabigatran was non-inferior at lower doses also. This analysis aimed to look at the main trial outcomes specifically in relation to each participating centre&#8217;s mean time in the therapeutic range (cTTR) in the warfarin population, which could have influenced patient outcomes.<!--more--><\/p>\n<p>In the RE-LY trial, 1\u20088113 patients at 951 sites were randomly assigned to 110\u00a0mg or 150\u00a0mg dabigatran twice daily versus warfarin dose adjusted to INR 2-3. The cTTR was estimated by averaging TTR for individual warfarin-treated patients calculated by the Rosendaal method. The outcomes of the trail were then compared across quartiles of cTTR.<\/p>\n<p>No significant interactions were seen between cTTR and prevention of stroke and systemic embolism with either low (p=0.89) or high dose (p=0.2). Similarly, no significant interactions were seen with low- or high-dose dabigatran versus warfarin with regards to intracranial bleeding. Rates of major bleeding were lower with low-dose dabigatran 110\u00a0mg than with warfarin irrespective of cTTR, however when comparing high-dose dabigatran with warfarin a significant interaction was seen between cTTR and major bleeding (p=0.03). Similar rates of the composite outcome of all cardiovascular events and total mortality were seen at high cTTR, but not at low cTTR (see\u00a0<a id=\"xref-fig-1-1\" href=\"http:\/\/heart.bmj.com\/content\/96\/24\/2041.full#F1\">figure 1<\/a>).<\/p>\n<figure id=\"attachment_419\" aria-describedby=\"caption-attachment-419\" style=\"width: 300px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" class=\"size-medium wp-image-419\" title=\"Figure1\" src=\"https:\/\/blogs.bmj.com\/heart-journalscan\/files\/2010\/12\/Figure13-300x175.gif\" alt=\"Time to primary outcome in centres with the worst international normalised ratio control (&lt;57.1% of the time in the target range). Republished with permission from The Lancet.\" width=\"300\" height=\"175\" srcset=\"https:\/\/blogs.bmj.com\/heart\/files\/2010\/12\/Figure13-300x175.gif 300w, https:\/\/blogs.bmj.com\/heart\/files\/2010\/12\/Figure13.gif 440w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><figcaption id=\"caption-attachment-419\" class=\"wp-caption-text\">Time to primary outcome in centres with the worst international normalised ratio control (&lt;57.1% of the time in the target range). Republished with permission from The Lancet.<\/figcaption><\/figure>\n<h4>Conclusions<\/h4>\n<p>This analysis of the data from the RE-LY trial confirms the benefits of dabigatran were consistent regardless of the participating centres&#8217; quality of INR control, although the advantages of dabigatran were greater at sites with poor INR control.<\/p>\n<p>\u25b6\u00a0<strong>Wallentin L<\/strong>, Yusuf S, Ezekowitz MD,\u00a0<em>et al<\/em>. Efficacy and safety of dabigatran compared with warfarin at different levels of international normalised ratio control for stroke prevention in atrial fibrillation: an analysis of the RE-LY trial.\u00a0<em>Lancet<\/em> 2010. doi:<a href=\"http:\/\/dx.doi.org\/10.1016\/S0140-6736(10)61194-4\">10.1016\/S0140-6736(10)61194-4<\/a>.<!--TrendMD v2.4.8--><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Dabigatran etecxilate is a novel anti-coagulant that acts a direct thrombin inhibitor and provides stable anticoagulation at a fixed dose without any need for a laboratory control. In the RE-LY trial (Randomised Evaluation of Long-term Anticoagulation Therapy), dabigatran was shown to reduced strokes and peripheral embolic events in patients with atrial fibrillation when compared to [&#8230;]<\/p>\n<p><a class=\"btn btn-secondary understrap-read-more-link\" href=\"https:\/\/blogs.bmj.com\/heart\/2010\/12\/15\/evidence-mounts-to-re-ly-on-dabigatran\/\">Read More&#8230;<\/a><\/p>\n","protected":false},"author":141,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[279],"tags":[],"class_list":["post-418","post","type-post","status-publish","format-standard","hentry","category-general-cardiology"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Evidence mounts to RE-LY on dabigatran - Heart<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/blogs.bmj.com\/heart\/2010\/12\/15\/evidence-mounts-to-re-ly-on-dabigatran\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Evidence mounts to RE-LY on dabigatran - Heart\" \/>\n<meta property=\"og:description\" content=\"Dabigatran etecxilate is a novel anti-coagulant that acts a direct thrombin inhibitor and provides stable anticoagulation at a fixed dose without any need for a laboratory control. 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